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Optimized Programming in Spinal Cord Stimulation (SCS) System (OP)

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ClinicalTrials.gov Identifier: NCT00871819
Recruitment Status : Completed
First Posted : March 30, 2009
Results First Posted : April 4, 2012
Last Update Posted : November 27, 2013
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions Neuropathic Pain
Pain
Intervention Device: Precision Spinal Cord Stimulation (SCS)
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Spinal Cord Stimulation Group
Hide Arm/Group Description Spinal Cord Stimulation (SCS) Treatment Group
Period Title: Overall Study
Started 20
Completed 20
Not Completed 0
Arm/Group Title Spinal Cord Stimulation Group
Hide Arm/Group Description Spinal Cord Stimulation (SCS) Treatment Group
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
  65.0%
>=65 years
7
  35.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
60  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
9
  45.0%
Male
11
  55.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Correlation Coefficient Between Dorsal Root Paresthesia (Total Pixels Derived From Digital Drawing) at Maximum-comfortable Stimulation Level and Anode-cathode Separation Distance (mm)
Hide Description [Not Specified]
Time Frame Immediately post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Subjects
Hide Arm/Group Description:
All enrolled subjects
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Correlation coefficient
0.6202
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Spinal Cord Stimulation Group
Hide Arm/Group Description Spinal Cord Stimulation (SCS) Treatment Group
All-Cause Mortality
Spinal Cord Stimulation Group
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Spinal Cord Stimulation Group
Affected / at Risk (%)
Total   0/20 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Spinal Cord Stimulation Group
Affected / at Risk (%)
Total   0/20 (0.00%) 
Small number of subjects; technical outcomes not necessarily predictive of therapeutic effectiveness.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nitzan Mekel-Bobrov, Ph.D.
Organization: Boston Scientific
Phone: (661) 949-4537
EMail: Nitzan.Mekel-Bobrov@bsci.com
Layout table for additonal information
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00871819    
Other Study ID Numbers: A2008
First Submitted: March 27, 2009
First Posted: March 30, 2009
Results First Submitted: February 13, 2012
Results First Posted: April 4, 2012
Last Update Posted: November 27, 2013